To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma
NCT ID: NCT05363202
Last Updated: 2022-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
790 participants
INTERVENTIONAL
2022-04-15
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.)
Fluticasone propionate Inhalation Aerosol 44 mcg
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
FLOVENT HFA
FLOVENT HFA 44 mcg
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Placebo of Fluticasone propionate inhalation aerosol 44 mcg
Matching Placebo inhaler
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Interventions
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Fluticasone propionate Inhalation Aerosol 44 mcg
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
FLOVENT HFA 44 mcg
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Matching Placebo inhaler
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of asthma for at least 12 months prior to screening
3. Pre-bronchodilator FEV1 of more than or equal to 45 % and less than or equal to 85 %.
4. Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to screening
5. Currently non-smoking;
6. More than or equal to 15 % reversibility of FEV1 within 30 min following 360 mcg of Albuterol/salbutamol inhalation (pMDI) at screening
7. Ability to discontinue their asthma controller medication safely
8. Ability to replace short-acting β agonists (SABAs) ongoing at screening with Albuterol/salbutamol inhaler.
9. Women of childbearing potential must be willing to consistently use an appropriate method of contraception.
10. Willingness to give their written informed consent to participate in the study.
11. Is willing to comply with all aspects of the protocol.
12. Ability to follow training given for study related procedures and assessments in the opinion of the Investigator.
Exclusion Criteria
2. Significant respiratory disease other than asthma
3. Evidence or history of clinically significant medical, surgical or psychiatric disease or laboratory abnormalities.
4. Known hypersensitivity to any sympathomimetic drug.
5. Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening.
6. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit
7. Subjects who required biologic agents for asthma systemic or oral corticosteroids (for any reason), within the past 6 months prior to screening
8. Evidence or history of oral candidiasis, active tuberculosis, hypercorticism, adrenal suppression, or eye problems.
9. Female subjects who are pregnant or breast-feeding or planning to be pregnant.
10. Currently enrolled in another clinical study or used any investigational product (study drug), study drug, or device within 30 days or 5 elimination half-lives, whichever is longer, preceding informed consent.
11. Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol.
18 Years
65 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals Ltd. India
INDUSTRY
Responsible Party
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Principal Investigators
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Ameet Daftary
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals Ltd
Locations
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Investigational Site 9
Ahmedabad, Gujarat, India
Investigational Site 2
Aurangabad, Maharashtra, India
Investigational Site 6
Nagpur, Maharashtra, India
Investigational Site 16
Nashik, Maharashtra, India
Investigational Site 11
Nashik, Maharashtra, India
Investigational Site 10
Nashik, Maharashtra, India
Investigational Site 3
Pune, Maharashtra, India
Investigational Site 1
Pune, Maharashtra, India
Investigational Site 4
Jaipur, Rajasthan, India
Investigational Site 13
Hyderabad, Telangana, India
Investigational Site 5
Hyderabad, Telangana, India
Countries
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Central Contacts
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Other Identifiers
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GLK 2101
Identifier Type: -
Identifier Source: org_study_id
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